Publications

Identification and Biosynthesis of an N-Glucuronide Metabolite of Camonsertib

The emerging use of qPCR and dPCR in regulated bioanalysis and absence of regulatory guidance on assay validations for these platforms has resulted in discussions…

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Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development

The emerging use of qPCR and dPCR in regulated bioanalysis and absence of regulatory guidance on assay validations for these platforms has resulted in discussions…

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Validation of Anti‑Adeno Associated Virus Serotype rh10 (AAVrh.10) Total and Neutralizing Antibody Immunogenicity Assays

Immunogenicity assessment of Adeno-Associated Virus (AAV) vectors is a critical part of gene therapy drug development. Whether the assays are used for inclusion/exclusion criteria or…

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Evaluation of Cellular Immune Response to Adeno‑Associated Virus‑Based Gene Therapy

The number of approved or investigational late phase viral vector gene therapies (GTx) has been rapidly growing. The adeno-associated virus vector (AAV) technology continues to…

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Bioanalytical Assay Strategies And Considerations For Measuring Cellular Kinetics

Drug development has been evolving dramatically over the past several decades to counter the unmet challenge of previously untreatable diseases. Novel and refined technologies have…

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Anti‑drug Antibody Sample Testing and Reporting Harmonization

A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate communication of immunogenicity findings and expedient review by industry and…

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Comparison of Titer and Signal to Noise (S/N) for Determination of Anti‑drug Antibody Magnitude Using Clinical Data from an Industry Consortium

During biotherapeutic drug development, immunogenicity is evaluated by measuring anti-drug antibodies (ADAs). The presence and magnitude of ADA responses is assessed using a multi-tier workflow…

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Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories

The use of molecular techniques in the bioanalytical laboratory is becoming more common as the number of gene and cell therapy products continues to increase.…

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Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices, June 2019

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Developed by the Biomarker Assay Collaborative Evidentiary Considerations Writing Group, Critical Path Institute (C-Path) This Points to Consider document was originally designed to establish consensus…

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Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment

Abstract The American Association of Pharmaceutical Scientists (AAPS) biosimilar focus group on nonclinical and clinical assays has developed this manuscript to guide the industry on…

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